3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 16MM

Additional Manufacturer Narrative

DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE RECEIVED FOR EVALUATION THE 9-HOLE STAINLESS STEEL WRIST FUSION PLATE IS DESIGNED TO BE MANUFACTURED OF IMPLANT QUALITY 316L STAINLESS STEEL, PER ASTM F138. THE HOLES AND HOLE LOCATIONS ARE DIMENSIONED APPROPRIATELY FOR THE ASSOCIATED INDICATIONS, AND ARE STANDARD 3.5MM AND 2.7MM SYNTHES COMBI HOLES. THE PLATE IS ALSO DESIGNED TO BE ADEQUATELY THICK FOR THE ASSOCIATED INDICATIONS, AND THE ELECTROPOLISH FINISH IS PER SYNTHES STANDARD. THE PACKAGING, LABELING, AND STERILIZATION ARE PER SYNTHES STANDARDS, AND A TECHNIQUE GUIDE EXISTS TO EXPLAIN PROPER IMPLANTATION OF THE PLATE. ALL THE SCREWS ARE DESIGNED TO BE MANUFACTURED OF IMPLANT QUALITY 316L STAINLESS STEEL, PER ASTM F138. THEY ARE DESIGNED OF THE CORRECT DIAMETER - 2.7MM AND 3.5MM SCREWS - AND THE HEADS OF THE SCREWS ARE STANDARD 3.5MM AND 2.7MM SYNTHES LOCKING THREADS. THE HEAD OF THE CORTEX SCREW IS APPROPRIATELY DIMENSIONED TO FIT IN THE NON-LOCKING PORTION OF THE COMBI HOLE. THE PACKAGING, LABELING, AND STERILIZATION ARE PER SYNTHES STANDARDS, AND A TECHNIQUE GUIDE EXISTS TO EXPLAIN PROPER IMPLANTATION OF THE SCREWS. NO OTHER DESIGN FACTOR COULD HAVE CONTRIBUTED TO THE FAILURE OF THE DEVICE. PLACEHOLDER.

Description of Event or Problem

PATIENT WAS IMPLANTED WITH LCP WRIST FUSION STRAIGHT PLATE AND SCREW CONSTRUCT ON (B)(6) 2012. X-RAY TAKEN ON AN UNKNOWN DATE REVEALED A NON-UNION. REPORTEDLY THE PATIENT WAS NOT COMPLAINT OF PAIN. PATIENT WAS RETURNED TO THE OR ON (B)(6) 2013 AND THE PATIENT UNDERWENT A REVISION OF THE RIGHT WRIST FUSION. THE SURGEON REMOVED THE PLATE AND SCREWS. IT WAS REPORTED TWO 2.7MM LOCKING SCREWS HAD THE HEADS BROKEN OFF AND THE REMAINING PART OF THE TWO SCREWS WERE LEFT IN THE PATIENT (POSSIBLY 14 TO 16 MM) IN THE 3RD METACARPAL. PATIENT WAS REVISED WITH AN 8 HOLE, 3.5 LOCKING PLATE AND 8 SCREWS (4 LOCKING SCREWS AND 4 CORTICAL SCREWS). REPORTEDLY THE PROCEDURE WAS COMPLETED AS PLANNED. THIS IS 6 OF 8 REPORTS FOR THE SAME EVENT, (B)(4).

Additional Manufacturer Narrative

DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL PRODUCT CODE: HWC. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.